Therapy for prevention of renal failure using mesenchymal stem cells cultured in serum-free medium

Phase 1

Recruiting

• Conditions: Chronic kidney disease; Diabetic kidney disease, IgA nephropathy, Nephrosclerosis

• Registration Number: JPRN-jRCTb060220083
• Lead Sponsor: akashima Ayumu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-12
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Patient with written informed consent.
2) Patient with Performance Status (PS) 0 or 1.
3) Both genders, 18 to 80 years old.
4) Chronic kidney disease patients due to diabetic kidney disease, IgA nephropathy, or nephrosclerosis.
5) Patients with eGFR 30-60 mL/min/1.73 m2 and proteinuria (more than 0.15 g/gCre) for 3 months or more.

Exclusion Criteria

1) Patients with renal diseases other than diabetic kidney disease, IgA nephropathy, nephrosclerosis, or patients with primary and secondary nephrotic syndrome.
2) Patients with a history of renal transplantation or scheduled within 3 years.
3) Patients with active infectious diseases requiring intravenous administration of antimicrobial agents, antiviral drugs, and antifungal drugs.
4) Patients with positive for hepatitis B virus, hepatitis C virus, human Immunodeficiency virus (HIV), human T-cell leukemia virus 1 (HTLV-1) or syphilis.
5) Patients receiving corticosteroids, immunosuppressants, anticoagulants (warfarin) and antiplatelet drugs (including patients who received these within 3 months).
6) Diabetics not well controlled.
7) Patients with malignant neoplasm or history of malignant neoplasm within 5 years, or judged possibility of malignant tumor.
8) Patients with mental illness or drug dependence.
9) Patients with serious complications such as heart disease, respiratory disease and liver disease.
10) Patients with history of severe hypersensitivity or anaphylactic reaction.
11) Patients with or have a history of Allergies to penicillin antibiotics or aminoglycoside antibiotics.
12) Patients with bleeding, easy bleeding or abnormality in the blood coagulation system.
13) Patients with history of hypersensitivity to components of heparin preparations, history of heparin-induced thrombocytopenia.
14) Patients who have participated in clinical studies with intervention within 6 month, or who are participating in other clinical studies.
15) Patients who have received other cell therapies.
16) During pregnancy, lactation, may be pregnant or both men and women who do not agree to give birth control under the guidance of the investigator or investigator during the study period.
17) Patients judged by the doctor to be inappropriate for participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: AE, Severity, Frequency, Period, Reasonable Possibility

Secondary Outcome Measures

Name	Time	Method
Efficacy: Renal function, Urinalysis, Kidney size, Histological evaluation of the kidney